FDA cough/cold monograph correction
This article was originally published in The Tan Sheet
Executive Summary
Directions on menthol 5 mg or 10 mg single-ingredient or combination drugs for cough suppressant/oral anesthetic or antitussive/oral anesthetic uses should state "dissolve lozenge slowly in the mouth. Repeat every two hours as needed or as directed by a doctor" instead of "repeat every hour as needed," as stated in the OTC Drug Cough, Cold, Allergy, Bronchodilator & Antiasthmatic Combination Drug Products Final Monograph. FDA is slated to publish the correction to the final rule in the April 14 Federal Register. Final monograph was published in December 2002 (1"The Tan Sheet" Dec. 23, 2002, p. 3)...
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